Events

Alerta De Seguridad para Reusable Ophthalmic Measuring Instruments - Incision Gauge 3.5 / 4.0

Según Ministry of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Lithuania que fue producido por Stephens Instruments, USA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Número del evento
    2
  • Fecha
    2018-06-27
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lithuania.
  • Notas adicionales en la data
  • Causa
    Medical devices and their packaging do not bear the ce conformity marking, which does not comply with the requirements of articles 38 and 39 of the regulation; neither medical devices nor their packaging contain data on the manufacturer's authorized representative in the european economic area, which does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation; the batch / serial number is not specified, which does not meet the requirements of annex 1, paragraph 14.3.4 of the regulation; neither medical devices nor their packaging indicate any special medical device maintenance, use conditions, and warnings and / or precautions, which do not comply with annex 1, paragraph 14.3.9 of the regulation. - 14.3.11. requirements of sub-paragraphs.
  • Acción
    Do not allow to enter the Lithuanian market

Device

Reusable Ophthalmic Measuring Instruments - Incision Gauge 3.5 / 4.0

Manufacturer

Stephens Instruments, USA
  • Representante del fabricante
    UAB Fox Vision
  • Source
    MH